The present invention is directed to methods for stopping the leakage of blood from punctures in blood vessels, arterial and venous vessel walls, such as which occur during diagnostic and interventional cardiac and peripheral catheterizations and vascular, endoscopic and orthopedic surgical procedures through induced hemostasis.
The control of bleeding during and after surgical procedures is a critical undertaking, especially if the procedure is performed directly upon or involves the patient's arteries and veins. In particular, well over one million surgical procedures are performed annually which involve the insertion and removal of catheters into and from arteries and veins. The insertion of a typical catheter creates a puncture through the vessel wall and upon removal of the catheter leaves a puncture opening through which blood may escape and leak into the surrounding tissue. Medical personnel are typically required to provide constant and continuing care to a patent who has undergone a procedure involving an arterial or venous puncture to insure that post-operative bleeding is controlled. Unless the puncture site is closed clinical complications may result leading to increased hospital stays with the associated costs.
The control of post-operative leakage of blood from the puncture site has been accomplished in the past in a variety of ways. The most common practice involves application of manual compression directly over the puncture site to slow the blood flow and help hold the puncture closed while natural non-induced clot formation processes take place. However, compression alone can be time consuming, in some cases requiring application of continuous compression on the order of 60-90 minutes, and in some instances may require extension of the patient's stay in hospital. Of course, excessive restriction or interruption of blood flow is undesirable and is to be generally avoided given the risk that undesirable complications may result.
Various blood flow controlling devices (hemostats) have been developed which, although shortening the time required to achieve control (hemostasis), still are time consuming, and can be unnecessarily complicated, with regard to either the procedures or equipment required. Some devices, such as disclosed in Kensey, U.S. Pat. No. 4,744,364, involve the insertion into the arterial or venous vessel of an expandable, biodegradable member which, when deployed, acts to seal the vessel from the inside out. Such devices, however, can have the effect of partially impeding or slowing the flow of blood in the vessel leading to undesirable complications.
Another prior art technique for achieving stopping the leakage of blood is to place a degradable plug directly into the puncture opening, such as a biodegradable collagen plug. Such a procedure is described in the article "Immediate Sealing of Arterial Puncture Sites after Cardiac Catheterization and Coronary Angioplasty Using a Biodegradable Collagen Plug: Results of an International Registry" in the Journal of the American College of Cardiology, Vol. 21, No. 4, pp. 851-55. However, as acknowledged in that article, there is a potential for the inadvertent insertion of the collagen plug into the lumen of blood vessel, which could be hazardous to the patient. In order to avoid such insertion, various precautions must be taken, including precise measuring of the distance from the skin surface to the vessel, the use of specially designed oversized applicator devices and plug diameters to prevent passage through the puncture site and entry into the vessel.
Moreover, the typical prior art device serves to seal only a single puncture at a single site upon the vessel whereas often two punctures may be created such as would result when an instrument punctures the vessel wall and travels to and through the vessel wall opposite the initial puncture site. Prior art devices, such as VASOSEAL seal only a single puncture at a time necessitating repeated procedures.
It is an object of the present invention to provide a method for applying a sealant directly to the external wall of an arterial or venous puncture site.
It is a further object of the present invention to provide a simplified method for stopping the flow of blood from a puncture site by sealing a puncture in a blood vessel in a manner which does not require compression or ligation for extended periods of time.
It is another object of the present invention to provide a method for achieving such hemostasis and sealing without requiring an excessive number of special apparatus.
Still another object of the invention is to provide a method for achieving such hemostasis without requiring the insertion of any prosthesis or apparatus into the interior of the vessel itself, or presenting any risk of inadvertent blockage of the vessel through the introduction of a foreign body into the vessel interior.
Another object of the present invention is to provide an apparatus and method capable of sealing two or more vessel punctures at a time without requiring multiple procedures.
Yet another object of the present invention is to provide an apparatus for accomplishing the hemostasis using the method described.
These and other objects of the invention will become apparent in light of the present specification, claims and drawings.